Back to resultsEngaging Men From Blue-collar Industries in Weight Loss
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard behavioral weight loss program
Tailored behavioral weight loss program
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring occupation, Behavioral treatment
Eligibility Criteria
Inclusion criteria:
- Age 18 years and older
- Male
- Body mass index (BMI) > 25 kg/m2
- Employed >20 hours per week in an occupation classified as blue collar
- Ability to communicate in English
- Provision of signed and dated informed consent form
Exclusion criteria:
- History of bariatric surgery
- Diabetes managed with insulin
- Diagnosis of a serious mental illness
- Conditions contraindicated to exercise independently (determined using four questions of Physical Activity Readiness Questionnaire)
- Report of potentially hazardous alcohol use (ASSIST >27)
- Weight loss in the prior six months of 10 pounds or greater
- Body mass index ≥60 kg/m2, due to increased injury risk with exercise
- Diagnosis of an eating disorder
- Any major medical condition that could increase risk for injury or other contradictions for treatment, or high likelihood of attrition, as determined by the study team
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tailored treatment
Standard of care treatment
Arm Description
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Outcomes
Primary Outcome Measures
Participant satisfaction with the intervention
Acceptability of the intervention will be reported as participants satisfaction with the program rated on a 7 point scale
Recruitment response
Proportion of participants who enroll in study by recruitment message type
Secondary Outcome Measures
Retention rates for each intervention group
Proportion of participants who complete the final follow up assessment
Recruitment reach
Number of visits to study websites
Participant satisfaction with the intervention
Acceptability of the intervention will be reported as participants satisfaction with the program rated on a 7 point scale
Full Information
NCT ID
NCT05386238
First Posted
May 12, 2022
Last Updated
September 12, 2023
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05386238
Brief Title
Engaging Men From Blue-collar Industries in Weight Loss
Official Title
Engaging Men From Blue-collar Industries in Weight Loss: Study 3- Evaluating the Acceptability of Weight Loss Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Objectives*: Primary Objective: Aim 1: Examine the acceptability of tailored behavioral weight loss program and a standard program in men working in blue-collar occupations.
Aim 2: Compare recruitment approaches that vary on trust-based messaging to recruit men with overweight/obesity who work in blue-collar occupations.
Secondary Objectives: Determine the feasibility of retaining participants to a randomized trial over six months.
Detailed Description
Men working in blue-collar occupations have a high prevalence of overweight and obesity and have high rates of comorbidities associated with obesity. Unfortunately, these men are unlikely to participate in evidenced-based weight loss interventions. Further, few efficacious interventions have been developed that target this population for weight control. The purpose of this study is to test the feasibility and acceptability of tailored recruitment messages and a novel, tailored behavioral weight loss intervention in the context of a randomized trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
occupation, Behavioral treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored treatment
Arm Type
Experimental
Arm Description
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Arm Title
Standard of care treatment
Arm Type
Active Comparator
Arm Description
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Intervention Type
Behavioral
Intervention Name(s)
Standard behavioral weight loss program
Intervention Description
16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
Intervention Type
Behavioral
Intervention Name(s)
Tailored behavioral weight loss program
Intervention Description
16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
Primary Outcome Measure Information:
Title
Participant satisfaction with the intervention
Description
Acceptability of the intervention will be reported as participants satisfaction with the program rated on a 7 point scale
Time Frame
3 months
Title
Recruitment response
Description
Proportion of participants who enroll in study by recruitment message type
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Retention rates for each intervention group
Description
Proportion of participants who complete the final follow up assessment
Time Frame
6 months
Title
Recruitment reach
Description
Number of visits to study websites
Time Frame
Baseline
Title
Participant satisfaction with the intervention
Description
Acceptability of the intervention will be reported as participants satisfaction with the program rated on a 7 point scale
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Clinically significant weight loss
Description
Proportion of participants who achieve a weight loss >5% of initial weight
Time Frame
Baseline, 3, and 6 months
Title
Program perceptions
Description
Semi-structured interviews to evaluate participants perceptions of program
Time Frame
3 and 6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Identify as male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Age 18 years and older
Male
Body mass index (BMI) > 25 kg/m2
Employed >20 hours per week in an occupation classified as blue collar
Ability to communicate in English
Provision of signed and dated informed consent form
Exclusion criteria:
History of bariatric surgery
Diabetes managed with insulin
Diagnosis of a serious mental illness
Conditions contraindicated to exercise independently (determined using four questions of Physical Activity Readiness Questionnaire)
Report of potentially hazardous alcohol use (ASSIST >27)
Weight loss in the prior six months of 10 pounds or greater
Body mass index ≥60 kg/m2, due to increased injury risk with exercise
Diagnosis of an eating disorder
Any major medical condition that could increase risk for injury or other contradictions for treatment, or high likelihood of attrition, as determined by the study team
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa M Crane, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
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Engaging Men From Blue-collar Industries in Weight Loss
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